Instructions for Milistan cough tablets coated with a film coating No. 20
Composition
active ingredients: ambroxol hydrochloride, carbocysteine;
1 film-coated tablet contains ambroxol hydrochloride – 30 mg, carbocysteine – 200 mg;
excipients: corn starch, microcrystalline cellulose, sodium
methylhydroxybenzoate (E 219), sodium propylhydroxybenzoate (E 217), magnesium stearate, talc, colloidal anhydrous silica, sodium starch glycolate (type A);
coating material: hydroxypropylmethylcellulose, talc, titanium dioxide (E 171), polyethylene glycol 6000.
Dosage form
Film-coated tablets.
Main physicochemical properties: white, round, biconvex, film-coated tablets, with the inscription "MILISTAN" on one side and the inscription "COUGH" on the other side.
Pharmacotherapeutic group
Mucolytics. ATX code R05C B10.
Pharmacological properties
Pharmacodynamics
The drug is a combination of two ingredients – ambroxol and carbocysteine.
Ambroxol is an active metabolite of bromhexine. It normalizes pathologically altered secretion of glandular cells of the bronchial mucosa, promotes liquefaction of viscous bronchial secretion and facilitates its discharge by increasing mucociliary clearance, changes the ratio of serous and mucous components of sputum. Stimulates Clark cells and activates hydrolyzing enzymes, which also leads to a decrease in sputum viscosity. Ambroxol has secretomotor properties - stimulates the work of the ciliated epithelium of the bronchi, restores the drainage function of small bronchi and bronchioles. The drug stimulates the formation of endogenous surfactant, does not cause excessive secretion formation, reduces spastic bronchial hyperreactivity - one of the main factors in the development of bronchial asthma in allergies. Cough and sputum volume are significantly reduced.
Carbocysteine has a mucolytic and expectorant effect due to the activation of sialic transferase - an enzyme of goblet cells of the bronchial mucosa. Normalizes the quantitative ratio of acidic and neutral sialomucins, which helps reduce the viscosity of bronchial secretion. Facilitates sputum discharge by increasing mucociliary clearance, has antioxidant and pneumoprotective properties, which is due to the ability of sulfhydryl groups to bind free radicals. It also promotes the regeneration of the mucous membrane, normalizes its structure and activates the activity of the ciliated epithelium, restores the secretion of IgA (specific protection) and the number of sulfhydryl groups of mucus components (nonspecific protection).
Pharmacokinetics
After ingestion, Milistan for cough is almost completely absorbed in the digestive tract, penetrates well into the lung tissue. Absolute bioavailability when taken orally is 70-80%. The maximum concentration in blood plasma is reached approximately 2.5 hours after oral administration.
The half-life is 10 hours. It is excreted mainly in the urine.
Indication
Secretolytic therapy for acute and chronic bronchopulmonary diseases associated with impaired bronchial secretion and impaired mucus movement.
Contraindication
Known hypersensitivity to ambroxol hydrochloride, carbocysteine or to any of the other ingredients of the product, especially to sodium methylhydroxybenzoate or sodium propylhydroxybenzoate. In the case of rare hereditary conditions that may cause incompatibility with the excipients of the product (see section "Special warnings and precautions for use"), the use of the product is contraindicated.
Peptic ulcer of the stomach and duodenum during the exacerbation period. I trimester of pregnancy due to insufficient data on teratogenic and embryotoxic effects.
Interaction with other medicinal products and other types of interactions
Increases the effectiveness of glucocorticoid and antibacterial therapy in the treatment of inflammatory diseases of the upper and lower respiratory tract. However, it is not recommended to use it simultaneously with tetracycline antibiotics (except doxycycline), the interval between their administration should be at least 2 hours.
The simultaneous use of ambroxol and cough suppressants may lead to excessive mucus accumulation due to suppression of the cough reflex. Therefore, such a combination is possible only after a careful assessment by the doctor of the ratio of the expected benefit and the possible risk of use.
During treatment with carbocysteine, antitussives and agents that suppress bronchial secretion should not be used.
Simultaneous use of the drug Milistan for cough with theophylline enhances the effect of the latter.
The presence of ambroxol in the drug Milistan for cough may lead to an increase in the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and sputum.
Application features
The use of mucolytic agents can lead to impaired bronchial patency in infants. In children of the first year of life, the ability to clear the respiratory tract from bronchial secretions is limited due to age-related anatomical and physiological characteristics. Any mucolytic agents should not be used in infants.
Treatment should be reviewed in case of lack of effect or worsening of symptoms.
There have been a few reports of severe skin lesions: Stevens-Johnson syndrome and Lyell's syndrome, which coincided in time with the use of ambroxol. Most of them can be explained by the severity of the underlying disease and/or the simultaneous use of another drug. Therefore, if new skin or mucous membrane lesions appear, medical help should be sought immediately and treatment with ambroxol hydrochloride should be discontinued. Also, in the initial stage of Stevens-Johnson syndrome or Lyell's syndrome, patients may have non-specific, flu-like symptoms such as fever, aches, rhinitis, cough and sore throat. Symptomatic treatment with cough and cold medications may be mistakenly used for such non-specific, flu-like symptoms.
In case of impaired bronchial motility and increased mucus secretion (for example, in a rare disease such as primary ciliary dyskinesia), the drug should be used with caution, since ambroxol may increase mucus secretion.
Patients with impaired renal function or severe hepatic insufficiency should take the drug with caution only after consulting a doctor. When using ambroxol, as with any active substance that is metabolized in the liver and then excreted by the kidneys, there is an accumulation of metabolites that are formed in the liver in patients with severe renal insufficiency.
Careful medical supervision is necessary if purulent sputum is produced or if the patient has a high temperature.
The drug should be used with caution in the treatment of patients with a history of gastric or duodenal ulcer.
The medicine contains methylhydroxybenzoate, propylhydroxybenzoate, which may cause an allergic reaction (delayed in time).
Use during pregnancy or breastfeeding
Contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy, the drug is used after a careful assessment of the benefit to the mother/risk to the fetus (child), which is determined by the doctor.
It is not recommended to use during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies on the effect on the reaction speed when driving vehicles or working with other mechanisms have not been conducted. In case of dizziness, you should refrain from driving vehicles or other mechanisms.
Method of administration and doses
Adults and children over 12 years old - 1 tablet 3 times a day.
The course of treatment is 7-10 days.
Children
Use in children over 12 years of age. For children under 12 years of age, it is advisable to use other dosage forms of the drug (syrup). Treatment of children should be carried out under the supervision of a physician.
Overdose
Ambroxol was well tolerated after parenteral administration in doses up to 15 mg/kg/day and after oral administration up to 25 mg/kg/day. No severe signs of intoxication were observed after an overdose of ambroxol. Possible symptoms: stomach pain, nausea, vomiting, diarrhea, short-term anxiety.
Similar to preclinical studies of ambroxol, excessive overdose may lead to hypersalivation, retching, vomiting, and decreased blood pressure.
Emergency measures such as induction of emesis and gastric lavage are generally not indicated and should be reserved for acute intoxication. Treatment is symptomatic and supportive.
Adverse reactions
Immune system disorders: hypersensitivity reactions, including angioedema, anaphylactic reactions, anaphylactic shock.
Skin and subcutaneous tissue disorders: skin rashes (punctate, maculopapular, maculopapular, draining plaques), urticaria, pruritus, erythema, dermatitis, mucous membrane reactions, severe skin lesions: including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome).
Gastrointestinal: nausea, decreased sensitivity in the oral cavity, vomiting, diarrhea, dyspepsia, heartburn, stomach pain, abdominal pain, dry mouth, constipation, drooling, dry throat, gastrointestinal bleeding.
On the part of the respiratory system, chest organs and mediastinum: decreased sensitivity in the pharynx, rhinorrhea, dyspnea (as a symptom of a hypersensitivity reaction), dryness of the respiratory tract.
From the urinary system: dysuria.
Neurological disorders: dizziness, headache, dysgeusia (taste disorder).
Cardiac disorders: palpitations.
General disorders: general weakness, fever, mucous membrane reactions.
Due to the presence of methylhydroxybenzoate and propylhydroxybenzoate in the composition of the drug, allergic reactions may occur, possibly delayed. In case of side effects, it is recommended to reduce the dose or discontinue the drug.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging and out of reach.
for children a place.
Packaging
10 tablets in a blister. 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Mepro Pharmaceuticals Private Limited, India.
Location of the manufacturer and its business address
Unit II, Q-Road, Phase IV, GIDC, Wadhwan City, Surendranagar, Gujarat, IN 363 035, India.
Applicant
Mili Healthcare Limited, Great Britain.
Applicant's location
Fairfax House 15, Fulwood Place, London, WC1V 6AY, Great Britain/Fairfax House 15, Fulwood Place, London , WC1V 6AY , Great Britain .
